The deployment of intraluminal prostheses into the lumen of a patient from a remote location by the use of a deployment device or introducer has been disclosed in a number of patents and patent applications. For example, U.S. Pat. No. 4,562,596 entitled “Aortic Graft, Device and Method for Performing an Intraluminal Abdominal Aortic Aneurysm Repair”, which is herein incorporated by reference, proposes the retention of a self expanding graft within a sleeve until it is to be deployed, at which time the sleeve is withdrawn and the graft is allowed to expand. U.S. Pat. No. 4,665,918 entitled “Prosthesis System and Method”, which is herein incorporated by reference, proposes a system and method for the deployment of a prosthesis in a blood vessel. The prosthesis is positioned between a delivery catheter and an outer sheath and expands outwardly upon removal of the sheath.
United States Published Patent Application No. 20050060018 entitled “Prosthesis Deployment System,” which is herein incorporated by reference, discloses an introducer for an expandable endovascular prosthesis. A self-expanding prosthesis is radially disposed within a distal portion of an outer sheath. A dilator or positioner is radially disposed within a proximal portion of the outer sheath so that the dilator distal end engages the prosthesis proximal end. To deploy the prosthesis, the operator withdraws the outer sheath over the dilator portion and the prosthesis while holding the dilator portion steady, thereby exposing the prosthesis and allowing the prosthesis to expand radially outwardly. In practice, the outer sheath fits tightly over the dilator. Because of the tight fit, withdrawal of the sheath can be difficult, requiring a very tight grip on the dilator by the operator. However, the dilator has a relatively small diameter and does not provide an adequate gripping surface. There is a need in the art for an improved prosthesis deployment system that addresses this issue.
The outer sheath of a prosthesis deployment system should be flexible and capable of conforming to highly tortuous body lumen systems without deforming or kinking. The outer sheath should also be strong and capable of maintaining its shape during delivery. U.S. Pat. No. 5,380,304 entitled “Flexible, Kink-Resistant, Introducer Sheath and Method of Manufacture,” which is herein incorporated by reference, discloses an apparatus and method of manufacturing an introducer sheath for percutaneous vascular access. United States Published Patent Application No. 20010034514 entitled “Introducer Sheath,” which is herein incorporated by reference, discloses an improved introducer sheath apparatus. There is a need in the art for an improved prosthesis deployment system that addresses this issue.
Today, many endoluminal prostheses are radially self-expanding. Radially self-expanding prostheses are advantageous because they do not require complicated and bulky balloon catheter systems for deployment. Such prostheses present a challenge, however, in that once a prosthesis end is released and anchored into the body lumen, subsequent positioning can be difficult. This is particularly the case if the ends of the prosthesis include anchoring mechanisms to secure the prosthesis to the body lumen. As a consequence, many deployment devices have been proposed that allow the self-expanding prosthesis to be partially expanded while providing a mechanism for retaining the prosthesis ends until the prosthesis has been properly positioned.
For example, in United States Published Patent Application No. 20050060018, discussed above, the introducer comprises a retention section for retaining a proximal end of the prosthesis thereto. The proximal end of the prosthesis is retained by a trigger wire. The trigger wire can be removed from the introducer to release the proximal end of the prosthesis into the body lumen. The deployment system disclosed in United States Published Patent Application No. 20050060018 has various advantages over other delivery systems including that it provides the operator with greater control over the prosthesis during deployment before the proximal prosthesis end is released into the body lumen. However, it can be inconvenient and awkward for the operator to have to remove and store the trigger wire during a procedure. There is a need in the art for a prosthesis deployment system that has a trigger wire mechanism for retaining a prosthesis end, wherein the prosthesis end can be deployed without having to remove the trigger wire.
United States Published Patent Application No. 20050085890 entitled “Prosthesis Deployment System Retention Device,” which is herein incorporated by reference, discloses another introducer for an expandable endovascular prosthesis. The introducer comprises a retention section for retaining a proximal end of the prosthesis thereto, similar to that of United States Published Patent Application No. 20050060018. The introducer comprises an additional retention section for retaining a distal end of the prosthesis thereto. The prosthesis is retained in the distal retention section by a second trigger wire. The second trigger wire is removed from the introducer to release the distal end of the prosthesis into the body lumen. The invention disclosed in United States Published Patent Application No. 20050085890 has many of the same advantages and challenges of United States Published Patent Application No. 20050060018; described above.
PCT Patent Publication Number No. WO98/53761 entitled “A Prosthesis and a Method and Means of Deploying a Prosthesis,” United States Published Patent Application No. 20030233140 entitled “Trigger Wire System,” and United States Published Patent Application No. 20040098079 entitled “Thoracic Aortic Stent Graft Deployment Device” each disclose introducer devices having trigger wires that are adapted for retaining a portion of a prosthesis during deployment. The disclosures of PCT Patent Publication No. WO98/53761, United States Published Patent Application No. 20030233140, and United States Published Patent Application No. 20040098079 are herein incorporated by reference.
Many prosthesis delivery systems have haemostatic valve assemblies for controlling blood loss through the system during the procedure. Valve assemblies are disposed on the introducer and are adapted to provide a radial seal about various interventional devices used during the procedure. Valve sealing assemblies may comprise disk type automatic or self closing valves. Disk type valves have various advantages including that they are relatively inexpensive and they provide an adequate seal around a variety of interventional devices having a range of diameters. However, no single disk valve is capable of sealing over the entire range of interventional device diameters, for example between 0.089 cm (0.035 inches) and 0.635 cm (0.250 inches. United States Published Patent Application No 20050171479 entitled “Hemostatic Valve Assembly”, which is herein incorporated by reference, discloses an iris-type valve assembly for controlling a flow of liquid. There is a need in the art for a prosthesis deployment system having an improved haemostatic valve assembly that addresses this issue.
Finally, various published patent applications and patents disclose features that relate to various aspects of prosthesis deployment systems. These include, but are not limited to:
a. United States Published Patent Application No. 20040054396 entitled “Stent-Graft Fastening,” which is herein incorporated by reference, discloses arrangements for fastening stents onto grafts particularly for exposed stents.
b. PCT Patent Publication Number No. WO03/053287 entitled “Stent Graft with Improved, Graft Adhesion,” which is herein incorporated by reference, discloses arrangements on stent grafts for enhancing the adhesion of such stent grafts into walls of vessels in which they are deployed.
c. U.S. Pat. No. 5,720,776 entitled “Expandable Transluminal Graft Prosthesis for Repair of Aneurysm,” which is herein incorporated by reference, discloses improved barbs with various forms of mechanical attachment to a stent.
d. U.S. Pat. No. 6,206,931 entitled “Graft Prosthesis Materials,” which is herein incorporated by reference, discloses graft prosthesis materials and a method for implanting, transplanting replacing and repairing a part of a patient and particularly the manufacture and use of a purified, collagen based matrix structure removed from a submucosa tissue source.
e. PCT Patent Publication Number No. WO99/29262 entitled “Endoluminal Aortic Stents,”, which is herein incorporated by reference, discloses a fenestrated prosthesis for placement where there are intersecting arteries.
f. PCT Patent Publication Number No. WO03/034948 entitled “Prostheses for Curved Lumens,” which is herein incorporated by reference, discloses prostheses with arrangements for bending the prosthesis for placement into curved lumens.